Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial (CORTIFRENCH)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2026
  • participants needed
    1200
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 15 March 2022

Summary

Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.

A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.

Details
Condition Elective Surgery for Any Digestive Cancer
Treatment blood samples, Injection of methylprednisolone, Injection of sodium chloride
Clinical Study IdentifierNCT03875690
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >_18 years
Elective surgery for any digestive cancer (except purely hepatic surgery)
Patients operated in a curative intent
Patients who had given their written informed consent
Patients affiliated to a National health insurance scheme

Exclusion Criteria

Emergency surgery
Pregnant or breastfeeding women
Patients with an ongoing oral treatment by steroids
Palliative surgery
Exclusive liver surgery
Concomitant hyperthermic intraperitoneal chemotherapy
Patient with at least one contra-indication to methylprednisolone treatment
active infection
on course viral disease (particularly hepatitis, herpes, chickenpox, herpes zoster)
uncontrolled psychotic state
hypersensitivity to methylprednisolone or to one of its excipients
ASA grade >3
Persons subject to a measure of legal protection (guardianship, tutorship)
Persons subject to a court order
Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
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